{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "110697", "product_res_number": "Z-2089-2012", "event_date_initiated": "2012-04-30", "event_date_posted": "2012-07-26", "recall_status": "Open, Classified", "res_event_number": "62456", "product_code": "MEH", "k_numbers": [ "K092406" ], "product_description": "ABG II Modular Hip Stem\nStryker Howmedica Osteonics Corp. Mahwah, NJ 07430\nStryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland.\n\nThe ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.", "code_info": "510 K092406  all lots  (4845-4XXX and NLS/NLV)", "firm_fei_number": "3003070421", "recalling_firm": "Stryker Howmedica Osteonics Corp.", "address_1": "325 Corporate Drive", "city": "Mahwah", "state": "NJ", "postal_code": "07430", "additional_info_contact": "Ms. Colleen O'Meara\n201-972-2100", "reason_for_recall": "Stryker has updated the instruction for use (IFU) (product correction)for the ABGII Modular and Rejuvenate Modular Hip Systems. This is based on a reported rate of less than one percent for revisions potentially associated with fretting and or corrosion at or about the modular neck junction. On June 29, 2012, Stryker has decided to remove the affected product from the field since there may be an", "root_cause_description": "Device Design", "action": "Stryker sent an \"URGENT PRODUCT CORRECTION\" letter dated April 23, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Product Correction Acknowledgment Form for customers to complete and return via fax to 201-831-6069. Contact the firm at 201-831-5970 for questions regarding this notice.\nStryker sent and \"Urgent Update Product Recall\" Letter dated January 3, 2013 to all affected customers. The new letter includes updated corrective actions for patients. 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"3001049282", "3010287737", "3010206549", "3012725451", "1000149660", "3005562917", "3002808293" ], "device_name": "Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3353", "device_class": "2" } } ] }